Vectorious Medical Technologies is a young and dynamic, fast-growing startup company located in Tel-Aviv. Our company has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our clinical study, we have successfully implanted our sensory device in patients across Europe and Israel, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease.
As the company is continuously growing, we are now seeking a Risk Management Manager. As a Risk Management manager, you will lead the maintenance of the Risk Management system, as part of the Regulatory Affairs team.
What will you do?
- Support day-to-day responsibilities of maintaining the Risk Management System in compliance with international quality regulations (FDA and EU), g., ISO 14971, ISO 13485, 21 CFR 820 etc.
- Ongoing maintenance of the Risk Management files for all potential product/process risks –
- Design FMEA (including software), Process FMEA and Usability FMEA, risk controls and traceability mapping for identified risk controls including their verification of effectiveness, residual risk review and risk benefit analysis
- Continuous update following customer complaints or quality events
- Risk-Benefit evaluation of the product and adverse events
- Perform risk assessment as part of complaints, field corrective actions, design changes
- Identify opportunities for continuous improvement of risk management and quality systems
- Partner with other functions in the organization to encourage a spirit of risk management collaboration throughout the organization
- Supports internal and external audits of risk management activities
What do you need to bring with you?
- Bachelor’s degree in relevant discipline (Engineering, Science, Technical Discipline)
- 3+ years of experience in risk management for medical devices (active implants/multidisciplinary products – an advantage)
- Regulatory knowledge and experience with international quality regulations (FDA and EU), g., ISO 14971, ISO 13485, 21 CFR 820 etc.
- Experience with risk management tools and statistical tools
- A technical mindset with great attention to details
- Excellent collaboration and communication skills
- Multi-tasking, organized and hands-on
- Excellent English language skills (verbal and writing)
Tel Aviv 
